Components of Chlorhexidine Gluconate Dressing

Sponsor

CareFusion (Industry)

Overall Status

Completed

CT.gov ID

NCT01112020

Collaborator

(none)

Enrollment

Location

Arms

Duration (Days)

45.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the contents of a chlorhexidine-containing dressing after use.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: CHG Catheter Dressing Patch Device: Biopatch Device: Tegaderm CHG	Phase 1

Detailed Description

To characterize the chemical composition of the CHG (2% CHG) Catheter Dressing Patch as compared to Biopatch Protective Disk with CHG, and Tegaderm IV (intravenous) Securement Dressing over a wear period of 7 days.

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Official Title:

Components & Tolerability of Chlorhexidine Gluconate Dressing Patch Compared to BioPatch & Tegaderm Chlorhexidine Gluconate Securement Dressing After Application to Healthy Subjects Over a 7-day Period

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CHG Catheter Dressing Patch	Device: CHG Catheter Dressing Patch 2% CHG dressing applied to 7 sites
Active Comparator: Biopatch Biopatch Protective Disk with CHG	Device: Biopatch Biopatch applied to 7 sites
Active Comparator: Tegaderm CHG Tegaderm CHG IV Securement Dressing	Device: Tegaderm CHG Tegaderm CHG IV Securement Dressing applied to 7 sites

Arm

Intervention/Treatment

Experimental: CHG Catheter Dressing Patch

Device: CHG Catheter Dressing Patch

2% CHG dressing applied to 7 sites

Active Comparator: Biopatch

Biopatch Protective Disk with CHG

Device: Biopatch

Biopatch applied to 7 sites

Active Comparator: Tegaderm CHG

Tegaderm CHG IV Securement Dressing

Device: Tegaderm CHG

Tegaderm CHG IV Securement Dressing applied to 7 sites

Outcome Measures

Primary Outcome Measures

Chlorhexidine gluconate (CHG) level [1 week]
CHG level in dressing after 7 days exposure to CHG-containing test articles

Secondary Outcome Measures

Parachloroaniline (PCA) level [7 days]
PCA level in dressing after 7 days exposure to CHG-containing test articles

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Able to read, review and sign the Informed Consent
Willing to shower using the same soap/cleansers from the Screening Visit through the end of the study
Use study-approved contraceptive methods

Exclusion Criteria:

Participation in an investigational study within 28 days prior to dosing.
Clinically significant illness within 28 days prior to dosing.
History of allergic responses to chlorhexidine, chlorhexidine-containing products, glycerol, adhesives, latex
History of clinically significant skin disorders
History of Type I diabetes mellitus, insulin-dependent diabetes mellitus(IDDM)
History of significant dermatologic cancers (melanoma, squamous)
Known history of immunologic disorders
Use immunosuppressive or other proscribed medications
Use of skin products at the application site
Significant history of allergies to soaps, lotions, emollients, ointments, creams
History of drug or alcohol addiction within the past year
Pregnant, lactating, breast-feeding, or intends to become pregnant during the course of the study